New Cognition Enhancer for Alzheimer’s Disease
Background
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- Development of compound with new target for symptomatic treatment in Alzheimer’s disease
- Candidate drug improved cognitive performance in animal studies
- Different pharmacology for rodent versus human target; concerned about impact in human patients
- PET tracer available for drug exposure
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Proposed Quantitative Systems Pharmacology Solution
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- Calibration of neurotransmitter system using rodent fast cyclic voltammetry data combined with human imaging studies
- Implementation of functional pharmacological effect on human receptors of candidate drug
- Simulation of full dose-response in QSP model for cognitive readout
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Outcome: Nicholas (2013)
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- QSP model correctly predicted Phase I trial outcome
- QSP model provided biological hypothesis for translational disconnect
- Identification of new patient population for drug